Steerable medical device having an imaging system

ABSTRACT

Embodiments of the disclosure may include a medical device comprising an elongate member and a handle assembly connected to the elongate member. The handle housing may house a steering mechanism movable relative to the handle assembly and configured to steer the elongate member along a first plane and a second plane different from the first plane, a camera system configured to capture images from a distal end of the elongate member, and an illumination system configured to provide illuminating light from the distal end of the elongate member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority of U.S. ProvisionalApplication No. 61/585,090, filed Jan. 10, 2012, which is incorporatedby reference herein in its entirety.

FIELD OF THE DISCLOSURE

Embodiments of the present disclosure include medical devices, and moreparticularly, ureteroscopes including a handle assembly housing animaging system and a steering mechanism, and related methods of usingsuch medical devices.

BACKGROUND

A challenge in the exploration and treatment of internal areas of thehuman anatomy has been adequately visualizing the area of concern.Visualization may be especially troublesome in minimally invasiveprocedures in which small diameter, elongate instruments, such ascatheters or endoscopes, may be navigated through natural passagewaysand cavities of a patient to a treatment area.

Generally speaking, ureteroscopy is one procedure that may be performedto diagnosis and/or treat urinary tract diseases and ureteralstrictures. In conventional ureteroscopy, a ureteroscope may be insertedretrograde through the urinary tract such that diagnosis and treatmentof urinary tract abnormalities may occur under visualization.Ureteroscopes may include an elongate member that may encapsulate animage sensor, an illumination element, and a working channel. Theworking channel may allow for the passage of instruments, such asguidewires, stone retrieval baskets, and lasers. Moreover, someureteroscopes may also incorporate a steering mechanism, which may beactuated by the user to deflect a distal tip of the elongate member inone or more planes. Steering may typically be achieved via ex-vivomanipulation at a handle end of the ureteroscope.

Problems exist, however, in the use of conventional ureteroscopes. Forexample, after each successive urological procedure, conventionalureteroscopes must be cleaned and sterilized before the next use, whichdelays successive procedures. Furthermore, conventional ureteroscopesare non-disposable and require extensive and expensive maintenance.Sterilization delays and costs associated with purchasing and/orrepairing ureteroscopes have escalated costs for ureteroscopicprocedures and other medical procedures that utilize similarlyconfigured scopes. The medical devices and related methods of thepresent disclosure are directed to improvements in the existingtechnology.

SUMMARY

In accordance with an embodiment, a medical device may comprise anelongate member and a handle assembly connected to the elongate member.The handle housing may house a steering mechanism movable relative tothe handle assembly and configured to steer the elongate member, acamera system configured to capture images from a distal end of theelongate member, and an illumination system configured to provideilluminating light from the distal end of the elongate member. Themedical device may also comprise a connector configured to operablyconnect the medical device to a control module including one or moreprocessing units for operating the camera system and the illuminationsystem, wherein the connector may be configured to directly connect toand disconnect from the handle assembly.

Various embodiments of the disclosure may include one or more of thefollowing aspects: the steering mechanism may be configured to steer theelongate member along a first plane and a second plane different fromthe first plane; the connector may extend into the handle assembly andmay be configured to connect and disconnect the camera system and theillumination system to the control module; the camera system may includea camera card housed within the housing assembly and may be configuredto communicate imaging data associated with the camera system; thecamera system may include one or more wires housed within the housingassembly, wherein the one or more wires may extend through the elongatemember and may operably connect to an image sensor at a tip of theelongate member; the camera card and the one or more wires may beconfigured to operably connect to the connector; the illumination systemmay include one or more illumination units within the housing assemblyand may extend through the elongate member, wherein the one or moreillumination units may be configured to operably connect to theconnector; a tool port may be configured to deliver a tool through theelongate member, and a fluid port may be configured to deliver fluidthrough the elongate member, wherein the tool port and the fluid portmay form a Y-shaped structure extending from the handle assembly; theconnector may extend from the handle assembly via a connector hub,wherein the connector hub may be positioned on a distal end of thehandle assembly and may be angled towards the elongate member; thesteering mechanism may include a first cam, a second cam, and aplurality of control members housed within the housing assembly, whereinthe plurality of control members may be operably coupled to the firstand second cams and may extend through the elongate member, and whereinthe plurality of control members may be coupled to a distal portion ofthe elongate member; and the steering mechanism may include a firstactuator operably coupled to the first cam and a second actuatoroperably coupled to the second cam, wherein actuation of the firstactuator may steer the distal portion of the elongate member along thefirst plane, and actuation of the second actuator may steer the distalportion of the elongate member along the second plane.

In accordance with another embodiment, an elongate member for a medicaldevice may comprise a proximal portion including a proximal combinationof layers of material configured to provide pushability of the elongatemember, a medial portion including a medial combination of layers ofmaterial configured to provide passive deflection of the elongatemember, and a distal portion including a distal combination of layers ofmaterial configured to provide active deflection of the elongate member,wherein the proximal combination, the medial combination, and the distalcombination may be different from each other.

Various embodiments of the disclosure may include one or more of thefollowing aspects: the elongate member may house one or more controlmembers, one or more illumination units, an image sensor, and a workingchannel; the proximal combination may include an inner layer of a coiledmaterial and an outer layer of a polymeric material, the medialcombination may include an inner layer of a coiled material having alaser cut pattern and an outer layer of the polymeric material, and thedistal combination may include an inner layer of a plurality ofarticulation joints and an outer layer of the polymeric material; theproximal combination may include an innermost layer of a coiledmaterial, a middle layer of a braided material, and an outer layer of afirst polymeric material; the medial combination may include aninnermost layer of the coiled material, a middle layer of the braidedmaterial, and an outer layer of a second polymeric material less rigidthan the first polymeric material; and the distal combination mayinclude an innermost layer of a plurality of articulation joints, amiddle layer of the braided material, and an outer layer of the secondpolymeric material; the proximal combination may include an inner layerformed of a tube having a first laser cut pattern and an outer layer ofa polymeric material, the medial combination may include an inner layerformed of a tube having a second laser cut pattern different than thefirst laser cut pattern and an outer layer of the polymeric material,and the distal combination may include an inner layer formed of a tubehaving a third laser cut pattern different than the first laser cutpattern and the second laser cut pattern and an outer layer of thepolymeric material; the distal combination may include a first layer ofa polymeric material molded over the one or more control members, asecond layer surrounding the first layer and formed of a coiledmaterial, a third layer surrounding the first and second layers andformed of a first polymeric material, and a fourth layer surrounding thefirst, second, and third layers and formed of a second polymericmaterial different than the first polymeric material; the elongatemember may include a tip having an opening for one or more illuminationunits, an opening for an image sensor, and an opening for a workingchannel; the opening for the one or more illumination units may includea diffuser; and the opening for the one or more illumination units maycurve at least partially around the opening for the image sensor.

In this respect, before explaining multiple embodiments of the presentdisclosure in detail, it is to be understood that the present disclosureis not limited in its application to the details of construction and tothe arrangements of the components set forth in the followingdescription or illustrated in the drawings. The present disclosure iscapable of embodiments in addition to those described and of beingpracticed and carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein, as well as theabstract, are for the purpose of description and should not be regardedas limiting.

The accompanying drawings illustrate certain exemplary embodiments ofthe present disclosure, and together with the description, serve toexplain the principles of the present disclosure. As such, those skilledin the art will appreciate that the conception upon which thisdisclosure is based may readily be used as a basis for designing otherstructures, methods, and systems for carrying out the several purposesof the present disclosure. It is important, therefore, to recognize thatthe claims should be regarded as including such equivalent constructionsinsofar as they do not depart from the spirit and scope of the presentdisclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a medical device, according to an exemplary disclosedembodiment;

FIG. 2 illustrates a plan view of parts of a handle assembly of themedical device of FIG. 1, according to an exemplary disclosedembodiment;

FIG. 3 illustrates a camera system, an illumination system, and aconnector of the medical device of FIG. 1, according to an exemplarydisclosed embodiment;

FIG. 4 illustrates a schematic view of the medical device of FIG. 1operably connected to a control module, according to an exemplarydisclosed embodiment;

FIG. 5 illustrates a schematic view of the medical device of FIG. 1operably connected to a control module, according to an exemplarydisclosed embodiment;

FIG. 6 illustrates a perspective view of inner parts of the handleassembly of the medical device of FIG. 1, according to an exemplarydisclosed embodiment;

FIG. 7 illustrates a plan view of parts of a handle assembly of anothermedical device, according to an exemplary disclosed embodiment;

FIG. 8 illustrates a plan view of parts of a handle assembly of anothermedical device, according to an exemplary disclosed embodiment;

FIG. 9A illustrates a schematic view of an elongate member of a medicaldevice, according to an exemplary disclosed embodiment;

FIG. 9B illustrates a cross-sectional view of the elongate member ofFIG. 9A, according to an exemplary disclosed embodiment;

FIG. 9C illustrates another cross-sectional view of the elongate memberof FIG. 9A, according to an exemplary disclosed embodiment;

FIG. 9D illustrates another cross-sectional view of the elongate memberof FIG. 9A, according to an exemplary disclosed embodiment;

FIG. 10A illustrates a schematic view of another elongate member of amedical device, according to an exemplary disclosed embodiment;

FIG. 10B illustrates a cross-sectional view of the elongate member ofFIG. 10A, according to an exemplary disclosed embodiment;

FIG. 10C illustrates another cross-sectional view of the elongate memberof FIG. 10A, according to an exemplary disclosed embodiment;

FIG. 10D illustrates another cross-sectional view of the elongate memberof FIG. 10A, according to an exemplary disclosed embodiment;

FIG. 11A illustrates a schematic view of another elongate member of amedical device, according to an exemplary disclosed embodiment;

FIG. 11B illustrates a cross-sectional view of the elongate member ofFIG. 11A, according to an exemplary disclosed embodiment;

FIG. 11C illustrates another cross-sectional view of the elongate memberof FIG. 11A, according to an exemplary disclosed embodiment;

FIG. 11D illustrates another cross-sectional view of the elongate memberof FIG. 11A, according to an exemplary disclosed embodiment;

FIG. 12A illustrates a schematic view of another elongate member of amedical device, according to an exemplary disclosed embodiment;

FIG. 12B illustrates a cross-sectional view of the elongate member ofFIG. 12A, according to an exemplary disclosed embodiment;

FIG. 12C illustrates another cross-sectional view of the elongate memberof FIG. 12A, according to an exemplary disclosed embodiment;

FIG. 12D illustrates another cross-sectional view of the elongate memberof FIG. 12A, according to an exemplary disclosed embodiment;

FIG. 13 illustrates a tip of a medical device, according to an exemplarydisclosed embodiment;

FIG. 14 illustrates a tip of a medical device, according to an exemplarydisclosed embodiment;

FIG. 15 illustrates a tip of a medical device, according to an exemplarydisclosed embodiment;

FIG. 16 illustrates a safety clip for a medical device, according to anexemplary disclosed embodiment;

FIG. 17A illustrates a schematic view of an interchangeable lever systemfor a medical device, according to an exemplary disclosed embodiment;and

FIG. 17B illustrates a perspective view of the interchangeable leversystem of FIG. 17A, according to an exemplary disclosed embodiment.

DETAILED DESCRIPTION

Reference will now be made in detail to the exemplary embodiments of thepresent disclosure described above and illustrated in the accompanyingdrawings.

The terms “proximal” and “distal” are used herein to refer to therelative positions of the components of an exemplary medical device.When used herein, “proximal” refers to a position relatively closer tothe exterior of the body or closer to the physician, or other user,using the medical device. In contrast, “distal” refers to a positionrelatively further away from the surgeon, or other user, using themedical device or closer to the interior of the body.

FIG. 1 illustrates a medical device 1 according to an exemplaryembodiment. Medical device 1 may be any device configured to allow anoperator to access and view internal body anatomies of a patient, aswell as to deliver medical instruments, such as, for example, biopsyforceps, graspers, baskets, snares, probes, scissors, retrieval devices,lasers, and other tools, into the patient's body. Medical device 1 maybe inserted into a variety of body lumens and/or cavities, such as, forexample, any portion of a urinary tract including a ureter, agastrointestinal lumen including an esophagus, a vascular lumen, anairway, and the like.

For the purposes of the present disclosure, medical device 1 may be asterile, single-use, and disposable ureteroscope. Other types ofdevices, however, may be substituted for the ureteroscope, including, asexamples, an endoscope, a hysteroscope, a uteroscope, a bronchoscope, acystoscope, and the like.

Ureteroscope 1 may include a handle assembly 2 and an elongate member 3operably connected to handle assembly 2. Elongate member 3 may be, forexample, a catheter, and configured to be at least partially insertedinto a body of a patient. Elongate member 3 may be flexible, or mayinclude one or more portions that are flexible, to allow elongate member3 to be maneuvered within the body and traverse tortuous anatomicallumens. For instance, elongate member 3 may be uniformly flexible or mayinclude a plurality of portions having varying degrees of flexibility orrigidity. Elongate member 3 may include a proximal portion 4, a distalportion 5, and a medial portion 6 disposed between proximal portion 4and distal end portion 5.

An image sensor 7 and an illumination unit 8 may be located at a tip 9of elongate member 3. Image sensor 7 may be configured to capture imagesand/or full-motion video images. Illumination unit 8 may be configuredto illuminate internal body pathways and/or cavities of a patient.

Handle assembly 2 may include a handle housing 10 to which one or moreports 12, 13 and a steering mechanism 11 may be operably coupled.

Ports 12, 13 may provide access to one or more channels extendingthrough elongate member 3. For example, port 12 may provide access forone or more medical tools to a working channel extending throughelongate member 3 and out tip 9. Additionally, port 13 may provideaccess through the working channel for a suitable fluid, such as wateror gas, for, as examples, irrigation and insufflation purposes.

Steering mechanism 11 may be configured to control the steering anddeflection of distal portion 5 of elongate member 3. Steering mechanism11 may include a first actuator 14 and a second actuator 15 configuredto control deflection of distal portion 5 between a substantially linearconfiguration and a curved, angled, or bent configuration. Distalportion 5 may be moved to a variety of different curved, angled, or bentconfigurations in a variety of different directions relative to alongitudinal axis 16 of elongate member 3. For example, actuating firstactuator 14 up and down relative to longitudinal axis 16 of elongatemember 3 may cause distal portion 5 to deflect in a first direction anda second direction of a first plane, and actuating second actuator 15side-to-side relative to longitudinal axis 16 of elongate member 3 maycause distal portion 5 to deflect in a first direction and a seconddirection of a second plane different than the first plane. Accordingly,steering mechanism 11 may provide four-way steering of distal portion 5of elongate member 3; however, it should also be appreciated thatsteering mechanism 11 may provide less or greater than four-way steeringof distal portion 5, depending on, for example, the volume and/or theshape of the internal body anatomies which may be traversed by elongatemember 3.

A connector 17 may also be coupled to handle assembly 2. As will bedescribed in more detail below, connector 17 may be configured tooperably connect and disconnect ureteroscope 1 to a suitable controlmodule. Although connector 17 is illustrated in FIG. 1 as projecting atan angle near a distal end 18 of handle assembly 2, it should also beappreciated that in certain embodiments, connector 17 may extend from aproximal end 19 of handle assembly 2.

FIG. 2 illustrates a plan view of inner parts of handle assembly 2 ofureteroscope 1 according to an exemplary embodiment. Handle assembly 2may include handle housing 10 comprising two half-portions (only onehalf-portion shown in FIG. 2) joined together by appropriate removablefasteners, such as screws and pins, or by appropriate non-removablefastening techniques, such as heat bonding. Handle housing 10 may housea camera system 20, an illumination system 21, steering mechanism 11,and connector 17.

FIG. 3 illustrates camera system 20, illumination system 21, andconnector 17 separated from handle housing 10 according to an exemplaryembodiment. Camera system 20 and illumination system 21 may form asingle, operating unit. In other words, a single connector 17 maycommunicate image and illumination data between the suitable controlmodule and camera system 20 and illumination system 21.

Camera system 20 may include image sensor 7, one or more electricalwires 22, and camera card 23. As discussed above, image sensor 7 may beany suitable type of image sensor configured to capture images and/orfull-motion video images in digital or any other suitable format, suchas, for example, a camera including a charged couple device (CCD) or aCMOS image sensor. Image sensor 7 may include a pixel count greater than20,000 pixels and less than 70,000 pixels. In addition, image sensor 7may include a field of view of at least 80°. One or more electricalwires 22 may be operably coupled to image sensor 7 and connector 17.Thus, image data captured by image sensor 7 may be transmitted throughone or more electrical wires 22, through connector 17, and to thecontrol module. Camera card 23 may also be connected to image sensor 7via one or more electrical wires 22 and to connector 17. Camera card 23may be, for example, any suitable circuit board configured to calibratethe captured images based on commands from the control module. Forexample, camera card 23 may include appropriate circuitry and memory andmay deserialize image data from image sensor 7 and may perform knownalgorithms, such as demosaicing, gain control, and white balance, toproduce a quality color image. The gain control may be implemented byadjusting the intensity of illumination system 21 and adjusting thegains applied to the signals by image sensor 7. Camera card 23 may alsoinclude isolation circuitry to prevent unacceptable radio frequencysusceptibility, emissions and interference, as well as unacceptableleakage currents in the event of an electrical failure. Camera card 23may also include circuitry for transmitting control signals to imagesensor 7 from the control module and for receiving image data from theimage sensor 7 and delivering the image data to the control module.Moreover, camera system 20 may include one or more features of theimaging system disclosed in U.S. Patent Application Publication No.2010/0076266 to Boulais et al., which is incorporated herein byreference in its entirety.

Illumination system 21 may include illumination unit 8 operablyconnected to connector 17. For the purposes of the present disclosure,illumination unit 8 may include, for example, one or more fiber opticcables configured to deliver light to a distal tip of fiber optic cableslocated at tip 9 of elongate member 3. It should be appreciated,however, that the fiber optic cables may be substituted for any knownillumination device, such as, for example, illumination light emittingdiodes (LEDs), illumination lenses, illumination rods, illuminationmirrors, solid light guides (e.g., lasers), and incandescent bulbs.

FIG. 4 illustrates a schematic representation of ureteroscope 1 coupledto a control module 24 according to an exemplary embodiment. As alludedto above, control module 24 may include imaging electronics configuredto process and/or transfer signals received from camera system 20,signals controlling camera system 20, and patient image data to adisplay (not shown) for viewing by a user. Control module 24 may alsoinclude an appropriate illumination source 25, such as a halogen sourceor an LED source, configured to deliver light to illumination unit 8,and illumination electronics configured to process and/or transfersignals controlling illumination source 25. One or more actuators orbuttons may be disposed on control module 24 to control illuminationsource 25 and camera system 20. Alternatively, the one or more actuatorsor buttons may be disposed on handle assembly 2. Furthermore, controlmodule 24 may include one or more features of the control cabinetdisclosed in U.S. Patent Application Publication No. 2010/0076266 toBoulais et al.

As illustrated in FIGS. 3 and 4, connector 17 may operably connecthandle assembly 2 to control module 24 and provide a communicationpathway between control module 24 and both camera system 20 andillumination system 21. For example, connector 17 may provide electronicsignaling pathways for image sensor 7 to transmit image data to controlmodule 24, for control module 24 to transmit image control signals toimage sensor 7 and camera card 23, and for control module 24 to controllight delivered from illumination source 25 to illumination unit 8. Insome embodiments, connector 17 may operably connect illumination unit 8to illumination source 25 contained in control module 24. It should beappreciated that in other embodiments, however, illumination source 25may be housed in handle assembly 2, and illumination unit 8 may beoperably connected to illumination source 25 within handle assembly 2.Illumination source 25 may then be operably coupled to control module 24via connector 17.

Connector 17 may include any appropriate linkage configured to providesignaling capabilities and communication between control module 24 andboth camera system 20 and illumination system 21, such as, for example,one or more electrical wires, an electrical conduit, and the like.Connector 17 may also include a suitable structure 26 configured toreadily attach to control module 24 and detach from control module 24,such as, for example, a detachable point-to-point adapter, a detachablesplice, and a detachable multi-port adapter. Accordingly, connector 17may operably link ureteroscope 1 to control module 24 when, for example,performing a procedure utilizing camera system 20 and illuminationsystem 21, and may readily detach ureteroscope 1 from control module 24when, for example, the procedure is completed, and the ureteroscope 1 isto be disposed.

As shown in FIG. 4, connector 17 may be fixed to handle assembly 2, andthus, the entire ureteroscope 1 may be attached and detached fromcontrol module 24 by connecting and disconnecting connector 17 fromcontrol module 24.

FIG. 5 illustrates another schematic representation of ureteroscope 1coupled to control module 24 according to an exemplary embodiment. Asshown in FIG. 5, a connector 17′ may be separately detachable from bothhandle assembly 2 and control module 24. In other words, a handle end 27of connector 17′ may include a first structure 28 configured to readilyattach to and detach from handle assembly 2. First structure 28 mayprovide a communication linkage between connector 17′ and illuminationsystem 21 and camera system 20, A control module end 29 of connector 17′may include a second structure 30 also configured to readily attach toand detach from control module 24. Second structure 30 may provide acommunication linkage between connector 17′ (and thus ureteroscope 1)and control module 24. Such a configuration may provide a reusableconnector 17′ for subsequent procedures. In other words, once aprocedure is completed, ureteroscope 1 may be disposed, and connector17′ may be sterilized and reused with a new ureteroscope 1 for anotherprocedure. Alternatively, connector 17′, like ureteroscope 1, may bereadily detached from control module 24 and disposed. In certainembodiments, it should be appreciated that connector 17′ may be fixedlyattached to control module 24 and readily detachable from handleassembly 2. Accordingly, ureteroscope 1 may be readily detached fromconnector 17′ and control module 24 and disposed after a procedure, andconnector 17′ may be reused with a new ureteroscope 1 for a subsequentprocedure.

Referring back to FIG. 2, camera system 20 and illumination system 21may be secured within handle housing 10 by any suitable means. Forexample, camera card 23 may be fastened to handle housing 10 byappropriate fasteners, such as screws and pins, or by appropriatefastening techniques, such as heat bonding and adhesive bonding.Furthermore, camera card 23 may be attached to a suitable groundingmeans 31 to discharge errant electrical surges and prevent damage tocamera board 23 from said surges. It should also be appreciated thatcamera board 23 may be hermetically-sealed in a fluid tightencapsulation to prevent damage from liquids.

One or more electrical wires 22 may extend from handle housing 10,through elongate member 3, and connect to image sensor 7 located at tip9 of elongate member 3. Illumination unit 8 may also extend from handlehousing 10, through elongate member 3, and terminate at tip 9 ofelongate member 3.

Connector 17 may extend from inside of handle housing 10 and exit handlehousing 10 via a connector hub 32. Connector 17 may be secured to handlehousing 10 by a suitable anchoring device 33, such as a strap, brace,and the like. Connector 17 may include a looped portion 34 positionedwithin handle housing 10. Looped portion 34 may prevent undesiredkinking of the communication linkage (e.g., electrical wires) associatedwith connector 17.

Steering mechanism 11 may be housed within handle housing 10 at proximalend 19 of handle assembly 2. As shown in FIG. 2, in addition to firstactuator 14 and second actuator 15, steering mechanism 11 may include afirst control member 35, a second control member 36, a third controlmember 37, a fourth control member 38, and a control member holdingmechanism 39. Control members 35, 36, 37, 38 may be coupled to first andsecond actuators 14, 15 and extend along handle housing 10 and throughelongate member 3. Furthermore, control members 35, 36, 37, 38 may eachbe coupled to elongate member 3 at or near tip 9.

A shaft hub 40 may be positioned within handle housing 10 near distalend 18 of handle assembly 2. Shaft hub 40 may be a Y-shaped structureand may be insert molded to connect a proximal end 41 of elongate member3 to handle assembly 2. Shaft hub 40 may include a first conduit 42 anda second conduit 43. First conduit 42 may lead control members 35, 36,37, 38, one or more electrical wires 22 of camera system 20, andillumination unit 8 of illumination system 21 into a lumen defined byelongate member 3. Second conduit 43 may lead a tube fluidly coupled toports 12, 13 into the working channel extending through elongate member3. Accordingly, one or more tools may be delivered through port 12 andthrough the working channel of elongate member 3, and irrigation fluidor insufflation gas may be delivered through the working channel ofelongate member 3 via port 13, without interfering with and potentiallydamaging control members 35, 36, 37, 38, one or more electrical wires22, and illumination unit 8.

FIG. 6 illustrates a perspective view of parts of handle assembly 2 ofureteroscope 1 according to an exemplary embodiment. As shown in FIG. 6,steering mechanism 11 may also include a first cam 44 coupled to firstactuator 14 and a second cam 45 coupled to second actuator 15. First cam44 and second cam 45 may be disposed within handle housing 10 andsupported in handle housing 10 by a frame 46. First cam 44 and secondcam 45 may be rotatably supported by a central arm, such as a boss (notshown), and each of first cam 44 and second cam 45 may be separatelyrotatable in response to actuation of first actuator 14 and secondactuator 15, respectively.

First cam 44 may be coupled to first control member 35 and secondcontrol member 36. As illustrated in FIG. 6, first and second controlmembers 35, 36 may be coupled to first cam 44 at spaced locations. Firstcontrol member 35 may be coupled to a portion of first cam 44 proximateto first actuator 14 (such as an end of cam 44 closest to actuator 14).Second control member 36 may be coupled to a portion of first cam 44different than the portion of first cam 44 coupled to first controlmember 35 (such as an end of cam 44 furthest from actuator 14).Moreover, first control member 35 and second control member 36 may bepositioned in respective slots on first cam 44 and secured thereto byany suitable fastener, such as screws, pins, and adhesives. Firstcontrol member 35 and second control member 36 each may be adapted tomove in response to movement of first cam 44. As discussed, firstcontrol member 35 and second control member 36 may be coupled toelongate member 3 at or near tip 9. Thus, first control member 35 andsecond control member 36 may deflect and steer elongate member 3 byactuation of first actuator 14.

First actuator 14 may be moved towards proximal end 19 and towardsdistal end 18 of handle assembly 2. In other words, first actuator 14may be rotated towards direction “A” and rotated towards direction “B”,as indicated by the directional arrow shown in FIG. 2. As first actuator14 is moved, first cam 44 may correspondingly rotate relative to frame46 and handle housing 10.

For instance, when first actuator 14 is moved towards proximal end 19 ofhandle assembly 2 (i.e., towards direction A shown in FIG. 2), first cam44 may rotate and move (or pull on) first control member 35. Firstcontrol member 35 then may move distal portion 5 of elongate member 3 inthe first direction along the first plane (e.g., up). First actuator 14may be moved towards distal end 18 of handle assembly 2 (i.e., towardsdirection B shown in FIG. 2) to return elongate member 3 to its startingposition (or a linear or relaxed position). In some embodiments, atleast one of first actuator 14 and first cam 44 may be biased such thatelongate member 3 may be maintained at the linear or relaxed position.When first actuator 14 is moved further towards distal end 18, first cam44 may rotate and move (or pull on) second control member 36. Secondcontrol member 36 then may move distal portion 5 of elongate member 3 inthe second direction along the first plane (e.g., down).

Similar to first cam 44, second cam 45 may be coupled to third controlmember 37 and fourth control member 38. As illustrated in FIG. 6, thirdand fourth control members 37, 38 may be coupled to second cam 45 atspaced locations. Third control member 37 may be coupled to a portion ofsecond cam 45 proximate to second actuator 15 (such as an end of cam 45closest to actuator 15). Fourth control member 38 may be coupled to aportion of second cam 45 different than the portion of second cam 45coupled to third control member 37 (such as an end of cam 45 furthestfrom actuator 15). Moreover, third control member 37 and fourth controlmember 38 may be positioned in respective slots on second cam 45 andsecured thereto by any suitable fastener, such as screws, pins, andadhesives. Third control member 37 and fourth control member 38 each maybe adapted to move in response to movement of second cam 45. Asdiscussed, third control member 37 and fourth control member 38 may alsobe coupled to elongate member 3 at or near tip 9. Thus, third controlmember 37 and fourth control member 38 may deflect and steer elongatemember 3 by actuation of second actuator 15.

Second actuator 15 may also be moved towards proximal end 19 and towardsdistal end 18 of handle assembly 2. In other words, second actuator 15may be rotated towards direction “C” and rotated towards direction “D”,as indicated by the directional arrow shown in FIG. 2. As secondactuator 15 is moved, second cam 45 may correspondingly rotate relativeto frame 46 and handle housing 10.

For instance, when second actuator 15 is moved towards proximal end 19of handle assembly 2 (i.e., towards direction C shown in FIG. 2), secondcam 45 may rotate and move (or pull on) third control member 37. Thirdcontrol member 37 then may move distal portion 5 of elongate member 3 inthe first direction along the second plane (e.g., left). Second actuator15 may be moved towards distal end 18 of handle assembly 2 (i.e.,towards direction D shown in FIG. 2) to return elongate member 3 to thelinear or relaxed position. Similar to first actuator 14 and first cam44, in some embodiments, at least one of second actuator 15 and secondcam 45 may be biased such that elongate member 3 is maintained at thelinear or relaxed position. When second actuator 15 is moved furthertowards distal end 18, second cam 45 may rotate and move (or pull on)fourth control member 38. Fourth control member 38 then may move distalportion 5 of elongate member 3 in the second direction along the secondplane (e.g., right).

As shown in FIGS. 2 and 6, control members 35, 36, 37, 38 may each be aBowden cable including an outer jacket 47 and an inner control wire 48,Bowden cables may be configured to transmit a mechanical pulling forceby movement of inner control wires 48 relative to outer jackets 47. Moreparticularly, outer jackets 47 may be configured to help transfer thepoint of relative motion from distal end portions of control wires 48 tomore proximal portions of wires 48.

Outer jacket 47 may be constructed of any suitable material. Forexample, outer jacket 47 may be of a composite construction, such as aspiral steel wire coated with plastic, or may be a single material, suchas a plastic or polymeric sheath. Control wire 48 may also beconstructed of any suitable material, such as stainless steel, tungsten,and Nitinol. Moreover, wire 48 may be a braided or bundled configurationof a plurality of materials, including, for example, a polymeric tubefilled with graphite, or may be a single strand of material, such as astainless steel wire or conduit.

Control members 35, 36, 37, 38 may each be anchored within handlehousing 10 by control member holding mechanism 39. Control memberholding mechanism 39 may also be configured to relieve tension tocontrol members 35, 36, 37, 38. Particularly, control member holdingmechanism 39 may include a sliding block not shown) and a springarrangement (not shown) coupled to each of control members 35, 36, 37,38, similar to the steering system tension control device disclosed inU.S. Patent Application Publication No. 2007/0232858 to Macnamara etal., which is incorporated herein by reference in its entirety.Particularly, outer jackets 47 of control members 35, 36, 37, 38 may befixed to the slidable block, and control wires 48 may extend proximallyfrom the slidable block and may be coupled to the first and secondactuators 14, 15. The spring may be positioned between the slidableblock and a proximal abutment (not shown) of control member holdingmechanism 39. When outer jackets 47 are under compression (due to, e.g.,significant bending or steering of the elongate member 3) sufficient toovercome the counteracting force of the spring, the slidable block willgive and proximally slide to compress the spring. Such action mayrelieve the compression on one or all of outer jackets 37, therebyrelieving the tension on control wires 48 and making control wires 48easier to move. It should be appreciated that the tension in controlwires 48 may not be allowed to exceed a predetermined limit that may beset to be the spring force of the spring.

Steering mechanism 11 may also include a lock system 49 configured tolock elongate member 3 in a desired linear or deflected position inresponse to an actuation by second actuator 15. Lock system 49 may besimilar to the lock mechanism disclosed in U.S. Pat. No. 7,922,650 toMcWeeney et al., which is incorporated herein by reference in itsentirety. Lock system 49 may include a tension knob 50 configured toactuate between a locked position, selectively tensioned positions, andan unlocked position. In use, a user may adjust the tension of secondactuator 15, as desired, by rotation of tension knob 50. Furthertightening of tension knob 50 may prevent actuation of second actuator15, thereby locking third and fourth control members 37, 38, and inturn, locking the linear or deflected position of elongate member 3.Although not illustrated in FIG. 6, it should also be appreciated that asimilar lock system may be associated with first actuator 14 that may beconfigured to lock elongate member 3 in a desired linear or deflectedposition in response to an actuation by first actuator 14.

FIG. 7 illustrates another embodiment of a handle assembly 200 accordingto an exemplary disclosed embodiment. Handle assembly 200 may includesubstantially the same features as handle assembly 2 discussed above. Asteering mechanism 211 of handle assembly 200, however, may include asingle actuator 212 for steering elongate member 3 in the first andsecond planes. Actuator 212 may be embodied as a joystick that issubstantially similar to the steering mechanism disclosed in U.S. PatentApplication Publication No. 2010/0121147 to Oskin et al., which isincorporated herein by reference in its entirety.

FIG. 8 illustrates another embodiment of a handle assembly 220 accordingto an exemplary disclosed embodiment. Handle assembly 220 may includesubstantially the same features as handle assembly 2 discussed above. Inthe embodiment of FIG. 8, a steering mechanism 221 may include a firstgear 222, a second gear 223, a first pulley 224, a second pulley 225, athird pulley 226, and a fourth pulley 227. First and second controlmembers 35, 36 may coupled to second gear 223 and may extend to distalportion 5 and be coupled to elongate member 3 at or near tip 9.Furthermore, first control member 35 may be partially wrapped aroundfirst pulley 224, and second control member 36 may be partially wrappedaround second pulley 225. First and second pulleys 224, 225 may reducethe load on first and second control members 35, 36 when, for example,first and second control members 35, 36 are retracted to deflect distalportion 5 of elongate member 3.

First gear 222 and second gear 223 may be coupled together by theirrespective teeth. First gear 222 may partially extend external a handlehousing 228 and include a lever 229 configured to actuate (i.e., rotate)first gear 222. Rotation of first gear 222 may then rotate second gear223, thereby pulling proximally either first control member 35 or secondcontrol member 36 based on the direction of actuation of lever 229. Forexample, actuating lever 229 downwards, as indicated by direction arrow“A” of FIG. 8, may cause second gear 223 to rotate and pull on firstcontrol member 35. First control member 35 then may move distal portion5 of elongate member 3 in the first direction along the first plane(e.g., down). Actuating lever 229 upwards, as indicated by directionarrow “B” of FIG. 8, may cause second gear 223 to rotate and pull onsecond control member 36. Second control member 36 then may move distalportion 5 of elongate member 3 in the second direction along the firstplane (e.g., up).

Although not illustrated in FIG. 8, it should be appreciated thatsteering mechanism 221 may also include a third gear and a fourth gearhaving a similar arrangement and features as first and second gears 222,223. Third and fourth control members 37, 38 may be coupled to thefourth gear and may extend distally to distal portion 5 and be coupledto elongate member 3 at or near tip 9. Third control member 37 may bepartially wrapped around third pulley 226, and fourth control member 38may be partially wrapped around fourth pulley 227. Third and fourthpulleys 226, 227 may reduce the load on third and fourth control members37, 38 when, for example, third and fourth control members 37, 38 areretracted to deflect distal portion 5 of elongate member 3. Actuating alever coupled to the third gear upwards and downwards may cause thefourth gear to rotate and pull on either third control member 37 orfourth control member 38 to deflect distal portion 5 of elongate member3 in either the first or second direction along the second plane (e.g.,left or right).

It should be appreciated that ureteroscope 1 may have an ergonomicstructure for improved handling by a user. For example, handle assembly200 of FIG. 7 may include a curved configuration for improved grippingby a user's hand. In addition, handle assembly 220 of FIG. 8 may includegrooves for the respective fingers of a user's hand, thus improving thegrip and comfort of ureteroscope 1.

FIGS. 9A-9D illustrate elongate member 3 according to an exemplaryembodiment. Elongate member 3 may vary in stiffness between proximalportion 4, medial portion 6, and distal portion 5. For example, proximalportion 4 may be stiffer than medial portion 6, and medial portion 6 maybe stiffer than distal portion 5. Such a configuration may minimizecompression and twisting of elongate member 3 to allow elongate member 3to be easily advanced through body cavities or lumens, while alsoproviding deflection of distal portion 5. Elongate member 3 may alsoinclude a hub interface 51 disposed on proximal end 41 of elongatemember 3. Hub interface 51 may connect elongate member 3 to handleassembly 2 and may provide torsion and tensile strength at theconnection point between elongate member 3 and handle assembly 2. In oneembodiment, hub interface 51 may be integrally formed with handleassembly 2 by, for example, injection molding. In other embodiments, hubinterface 51 may be non-integrally formed with handle assembly 2 and maybe connected thereto by, for example, adhesive bonding or mechanicalconnections, such as male and female threaded connections, quick lockconnectors, snap connectors, and the like. In certain embodiments,distal portion 5 may include a length between 3 and 5 centimeters,medial portion 6 may include a length between 1 and 3 centimeters, andproximal portion 4 may include a length between 55 and 65 centimeters.It should be appreciated, however, that each of proximal portion 4,medial portion 6, and distal portion 5 may include any other suitablelength.

FIGS. 9B-9D illustrate cross-sectional views of proximal portion 4,medial portion 6, and distal portion 5, respectively, according to anexemplary embodiment. Elongate member 3 may include an outer sleeve 52encasing proximal portion 4, medial portion 6, and distal portion 5.Outer sleeve 52 may comprise of any number of polymer jackets including,as examples, polyethylene, such as polyethylene having a molecularweight in the range of 50,000 to 100,000; nylon, such as nylon 12, nylon4-6, and nylon 6-6; Pebax (polyether block amides); polyurethane;polytetrafluoroethylene (PTFE); particularly fluorinated ethylenepropylene (FEP) copolymers; and polyethylene impregnated with PTFE.Outer sleeve 52 may vary the stiffness of elongate member 3, if desired,or may provide improved torque transfer and/or other desirablestructural properties. Additionally, outer sleeve 52 may be used as oneconvenient method for securing proximal portion 4, medial portion 6, anddistal portion 5 together. In the embodiments of FIGS. 9A-9D, outersleeve 52 may be formed of polyethylene.

In certain embodiments, outer sleeve 52 may include a hydrophiliccoating or a silicone coating to ease the passage of elongate member 3into the patient. Such a hydrophilic coating may be, as examples,N-vinyl pyrrolidone, polyvinyl alcohol, and polyvinyl pyrrolidone. Thehydrophilic coating may be accomplished by coating outer sleeve 52 witha primer, such as Bayhydrol 110 (an anionic dispersion of an aliphaticpolyester urethane resin in water/n-methyl-2pyrrolidone) and thenbonding a primary layer over the primer. The primary layer may be, asexamples, an acrylamide or a polyurethane-based acrylamide. Aliphaticpolyether and polyester polyurethanes also may be used as lubricouscoatings.

As shown in FIG. 9B, proximal portion 4 may include materials configuredto provide pushability, stiffness, and kink resistance to elongatemember 3. For example, proximal portion 4 may include a reinforcementsheath 53, encased by outer sleeve 52, that may extend from proximal end41 of elongate member 3 to or immediately proximal medial portion 6.Reinforcement sheath 53 may include a coiled configuration of tightlywound flat wire or polymeric elements. The coiled configuration mayprovide column strength and torsional rigidity to elongate member 3 atproximal portion 4, which may allow elongate member 3 to be advancedthrough body lumens and/or cavities. The coiled configuration may alsoprovide kink resistance to prevent proximal portion 4 from collapsingdue to bending forces on proximal portion 4. In certain embodiments,reinforcement sheath 53 may include a wall thickness between 0.003″ and0.06″, and may include a length between 65 cm and 70 cm.

As shown in FIGS. 9A and 9C, medial portion 6 may include materialsconfigured to provide passive deflection of elongate member 3. Forexample, medial portion 6 may include a deflection sheath 54, encased byouter sleeve 52, and comprised of a similar coiled configuration ofmaterial as reinforcement sheath 53; however, the coiled material ofmedial portion 6 may include a suitable laser cut pattern 55. FIG. 9Ashows a cut away portion 56 of outer sleeve 52 for the purposes ofillustrating laser cut pattern 55. Laser cut pattern 55 may includeslots cut 180° relative to each other and spaced an even distance apartfrom each other. The slots may be V-shaped, semi-circle, wave-shaped, orany other suitable shape. In certain embodiments, the slots may includea pitch of 0.008″, and each slot may include a width between 0.001″ and0.0025″. Accordingly, deflection sheath 54 may include a suitableflexibility to deflect and conform to the shape and anatomies of bodylumens and/or cavities. In some embodiments, medial portion 6 may beconfigured to deflect up to 105° relative to longitudinal axis 16 ofelongate member 3 in one or more directions from longitudinal axis 16.

As shown in FIGS. 9A and 9D, distal portion 5 may include materialsconfigured to provide active deflection of elongate member 3. In otherwords, distal portion 5 may be configured to deflect in one or moredirections (e.g., the first and second direction along the first planeand the first and second directions along the second plane, such as up,down, left, and right) upon actuation of control members 35, 36, 37, 38.Distal portion 5 may include, for example, a plurality of deflectionsegments 57 encased by outer sleeve 52. FIG. 9A shows a cut away portion58 of outer sleeve 52 for the purposes of illustrating deflectionsegments 57. Deflection segments 57 may include, for example, aplurality of articulation joints substantially similar to any of thearticulation joints disclosed in U.S. Patent Application Publication No.2010/0076266 to Boulais et al. In certain embodiments, deflectionsegments 57 may be configured to deflect distal portion 5 up to 270°relative to longitudinal axis 16 of elongate member 3 along the firstplane and along the second plane. In other embodiments, deflectionsegments 57 may be configured to deflect distal portion 5 up to 270°relative to longitudinal axis 16 of elongate member 3 in one of thefirst plane and the second plane, and up to 90° relative to longitudinalaxis 16 of elongate member 3 in the other of the first plane and thesecond plane.

As shown in FIGS. 9B-9D, a working channel 59 may extend longitudinallythrough proximal portion 4, medial portion 6, and distal portion 5.Working channel 59 may be in communication with ports 12, 13 and may bedefined by an inner sheath 60 and an outer sheath 61. Inner sheath 60may be formed of any suitable material having a smooth surfaceconfigured to ease the passage of one or more instruments throughworking channel 59. For example, inner sheath 60 may be formed of PTFEor high density polyethylene. Outer sheath 61 may be comprised of anysuitable material configured to provide kink resistance, yet stillprovide flexibility for working channel 59. For example, outer sheath 61may include a braided configuration of tightly wound wires or polymericelements. It should be appreciated that in certain embodiments, apolymeric jacket may be disposed over outer sheath 61, including, asexamples, Pebax, polyimide, and fluorinated ethylene propylene.Furthermore, working channel 59 may taper from a larger diameter atproximal portion 4 to a smaller diameter at distal portion 5. Thetapering diameter of working channel 59 towards distal portion 5 mayhelp promote active deflection of distal portion 5. In addition, thetapering diameter of working channel 59 may promote an increased flowrate of a fluid delivered therethrough. For example, a suitable fluid,such as water, saline, or gas, introduced via port 13 and deliveredthrough tapering working channel 59 may have a higher flow rate as itexits tip 9 relative to a working channel having a substantiallyconstant diameter, since the smaller diameter of distal portion 5 mayrestrict the fluid traveling from the larger diameters of proximalportion 4 and medial portion 6.

FIGS. 9B-9D further illustrate that illumination units 8 of illuminationsystem 21 and electrical wires 22 of camera system 20 may extendlongitudinally through proximal portion 4, medial portion 6, and distalportion 5. It should be appreciated that illumination units 8 may bebundled together or may be separated, and electrical wires 22 may bebundled together or may be separated. In addition, control members 35,36, 37, 38 may extend longitudinally through proximal portion 4, medialportion 6, and distal portion 5. Control members 35, 36, 37, 38 may bedisposed 90° relative to each other radially around the lumen ofelongate member 3. Outer jackets 47 may terminate at or proximal todistal portion 5. In other words, only control wires 48 of controlmembers 35, 36, 37, 38 may extend along distal portion 5. The terminalends of outer jackets 47 may be attached to medial portion 6 by anysuitable fastener. Moreover, control wires 48 may be attached to aninner surface of distal portion 5, e.g., the inner surfaces ofdeflection segments 57, by any suitable fastener at or near tip 9.Alternatively, control wires 48 may be fastened within the walls ofdeflection segments 57. Accordingly, such a configuration of controlmembers 35, 36, 37, 38 may facilitate the deflection of distal portion5.

FIGS. 10A-10D illustrate another embodiment of an elongate member 300according to an exemplary embodiment. Similar to elongate member 3,elongate member 300 may vary in stiffness between a proximal portion304, a medial portion 306, and a distal portion 305. Elongate member 300may also include working channel 59, illumination units 8, electricalwires 22, and control members 35, 36, 37, 38 in a similar arrangement asdiscussed above with regards to FIGS. 9A-9D. In addition, elongatemember 300 may include hub interface 51.

Elongate member 300 may also include an outer sleeve 352 encasingproximal portion 304, medial portion 306, and distal portion 305. Outersleeve 352 may comprise of any number of polymer jackets. In theembodiments of FIG. 10A-10D, outer sleeve 352 may include a firstsection 341 formed of a material having a first rigidity, and a secondsection 342 formed of a material having a second rigidity less than thefirst rigidity. For example, first section 341 may be formed of highdurometer Pebax, and second section 342 may be formed of a low durometerPebax. The high durometer Pebax of first section 341 may span proximalportion 304 to promote pushability, torque, and kink resistance toelongate member 300, and the low durometer Pebax of second section 342may span medial portion 306 and distal portion 305 to facilitatedeflection of elongate member 300. Furthermore, it should be appreciatedthat first and second sections 341, 342 may be integrally formed by, forexample, extrusion, or may be separate sections attached together by asuitable fastening means, such as an adhesive or weld.

As shown in the cross-sectional views of elongate member 300 in FIGS.10B and 10C, proximal portion 304 and medial portion 306 may include afirst reinforcement sheath 353 surrounding a second reinforcement sheath363 that may both extend from a proximal end 341 of elongate member 300to or immediately proximal distal portion 305. First reinforcementsheath 353 may include a braided configuration of tightly wound wires orpolymeric elements. Second reinforcement sheath 363 may include a coiledconfiguration of tightly wound flat wire or polymeric elements.

The combination of the high durometer Pebax of first section 341, firstreinforcement sheath 353, and second reinforcement sheath 363 mayprovide pushability, column strength, and torsional rigidity to elongatemember 300 at proximal portion 304, which may allow elongate member 300to be advanced through body lumens and/or cavities. Moreover, such acombination may provide kink resistance to prevent proximal portion 304from collapsing due to bending forces on proximal portion 304.

The combination of the low durometer Pebax of second section 342, firstreinforcement sheath 353, and second reinforcement sheath 363 mayprovide passive deflection of elongate member 300 at medial portion 306.Accordingly, such a combination at medial portion 306 may provide asuitable flexibility for elongate member 300 to deflect and conform tothe shape and anatomies of body lumens and/or cavities.

As shown in FIG. 10A and the cross-sectional view of elongate member 300in FIG. 10D, distal portion 305 may include materials configured toprovide active deflection of elongate member 300. In other words, distalportion 305 may be configured to deflect in one or more directions(e.g., the first and second direction along the first plane and thefirst and second directions along the second plane) upon actuation ofcontrol members 35, 36, 37, 38. Similar to distal portion 5 of elongatemember 3, distal portion 305 of elongate member 300 may include, forexample, deflection segments 57 encased by first reinforcement sheath353 and outer sleeve 352. FIG. 10A shows a cut away portion 356 of outersleeve 352 and first reinforcement sheath 353 for the purposes ofillustrating deflection segments 57.

FIGS. 11A-11D illustrate another embodiment of an elongate member 400according to an exemplary embodiment. Similar to elongate member 3,elongate member 400 may vary in stiffness between a proximal portion404, a medial portion 406, and a distal portion 405. Elongate member 400may also include working channel 59, illumination units 8, electricalwires 22, and control members 35, 36, 37, 38 in a similar arrangement asdiscussed above with regards to FIGS. 9A-9D. In addition, elongatemember 400 may include hub interface 51.

Elongate member 400 may include outer sleeve 52 encasing proximalportion 404, medial portion 406, and distal portion 405. Outer sleeve 52may comprise any number of polymer jackets. In the embodiments of FIGS.11A-11D, outer sleeve 52 may be formed of polyethylene.

As shown in the FIG. 11A and the cross-sectional views of elongatemember 400 in FIGS. 11B-11D, elongate member 400 may include a singletube 407 formed of, for example, stainless steel or polymeric materials,spanning proximal portion 404, medial portion 406, and distal portion405. Along proximal portion 404, tube 407 may include a first laser cutsection 408; along medial portion 406, tube 407 may include a secondlaser cut section 409; and along distal portion 405, tube may include athird laser cut section 410. First laser cut section 408 may include alaser cut pattern configured to promote pushability and torsionalstrength of elongate member 400. For example, first laser cut section408 may include a relatively small number of laser cut slots spacedrelatively far apart. In other words, first laser cut section 408 mayinclude slots having a relatively large pitch, such as, for example,between 0.04″ and 0.06″. Second laser cut section 409 may include alaser cut pattern configured to promote flexibility for passivedeflection and torsional strength of elongate member 400. For example,second laser cut section 409 may include a jigsaw pattern or a number oflaser cut slots greater than the number of slots in first laser cutsection 408 and having a smaller pitch relative to the slots of firstlaser cut section 408. Third laser cut section 410 may include a lasercut pattern configured to promote high flexibility for active deflectionand low torsional strength for elongate member 400. For example, thirdlaser cut section 410 may include a number of laser cut slots greaterthan the number of slots in both first laser cut section 408 and secondlaser cut section 409, and having a smaller pitch relative to the slotsin both first laser cut section 408 and second laser cut section 409.FIG. 11A shows cut away portions 418, 419, 420 of outer sleeve 52 forthe purposes of illustrating first, second, and third laser cut sections408, 409, 410.

FIGS. 12A-12D illustrate another embodiment of an elongate member 500according to an exemplary embodiment. Similar to elongate member 3,elongate member 500 may vary in stiffness between a proximal portion504, a medial portion 506, and a distal portion 505. Elongate member 500may also include working channel 59, illumination units 8, electricalwires 22, and control members 35, 36, 37, 38 in a similar arrangement asdiscussed above with regards to FIGS. 9A-9D. In addition, elongatemember 500 may include hub interface 51.

Elongate member 500 may include outer sleeve 52 encasing proximalportion 504, medial portion 506, and distal portion 505. Outer sleeve 52may comprise any number of polymer jackets. In the embodiments of FIGS.12A-12D, outer sleeve 52 may be formed of polyethylene.

As shown in the cross-sectional views of elongate member 500 in FIGS.12B and 12C, proximal portion 504 and medial portion 506 may includematerials configured to provide passive deflection of elongate member500. For example, proximal portion 504 and medial portion 506 mayinclude a single tube 507 formed of, for example, stainless steel orpolymeric materials, having a suitable laser cut pattern 508. FIG. 12Ashows cut away portions 518, 519 of outer sleeve 52 for the purposes ofillustrating laser cut pattern 508. Laser cut pattern 508 may includeslots cut 180° relative to each other and spaced an even distance apartfrom each other. The slots may be V-shaped, semi-circle, wave-shaped, orany other suitable shape. In certain embodiments, the slots may includea pitch of 0.008,″ each slot may include a width between 0.001″ and0.0025″. Accordingly, proximal and medial portions 504, 506 may includea suitable flexibility to deflect and conform to the shape and anatomiesof body lumens and/or cavities. In some embodiments, proximal portion504 and medial portion 506 may be configured to deflect up to 105°relative to longitudinal axis 16 of elongate member 500 in one or moredirections from longitudinal axis 16.

Distal portion 505 may be configured for active deflection of elongatemember 500 by, for example, actuation of control members 35, 36, 37, 38.As shown in the cross-sectional view of elongate member 500 in FIG. 12D,distal portion 505 may include a first layer 520 formed of a polymericmaterial, such as Pebax, a second layer 521 formed of a loosely coiledstainless steel wires or polymeric materials, and a third layer 522including a suitable polymeric material molded over control wires 48 ofcontrol members 35, 36, 37, 38. Actuation of control members 35, 36, 37,38 may deflect distal portion 505 up to 270° relative to longitudinalaxis 16 of elongate member 500 along the first plane and along thesecond plane. In other embodiments, distal portion 505 may be configuredto deflect up to 270° relative to longitudinal axis 16 of elongatemember 500 in one of the first plane and the second plane, and up to 90°relative to the longitudinal axis of elongate member 500 in the other ofthe first plane and the second plane.

FIG. 13 illustrates tip 9 of elongate member 3, 300, 400, 500 accordingto an exemplary embodiment, viewed from the distal end of elongatemember 3, 300, 400, 500. Tip 9 may include a distal cap 70 having anumber of openings on a distal face 71 of cap 70. The openings mayinclude an opening 72 for working channel 59, openings 73 forillumination units 8, and an opening 74 for image sensor 7. As shown inFIG. 13, image sensor 7 may be disposed between illumination units 8,thus providing adequate illumination of a desired site for imagecapture. In addition, openings 73 for illumination units 8 and opening74 for image sensor 7 may include windows or lenses to cover and protectillumination units 8 and image sensor 7 at distal face 71. Distal cap 70may be integrally formed with elongate member 3, 300, 400, 500, oralternatively, may be a separate structure attached to tip 9 of elongatemember 3, 300, 400, 500 by any suitable fastening means.

FIG. 14 illustrates another embodiment of a distal cap 80 according toan exemplary embodiment. Distal cap 80 may be substantially similar todistal cap 70 of FIG. 11. In addition, openings 81 for illuminationunits 8 of distal cap 80 may include one or more diffusers 82. Diffusers82 may be configured to spread the light discharged from illuminationunits 8 to produce a softer light and eliminate harsh light and hardshadows. Thus, the image captured by image sensor 7 may be softer andclearer. Diffusers 82 may include any suitable structure or materialsfor spreading the light from illumination units 8 including, asexamples, ground glass, opal glass, grayed glass, and various whiteopaque plastics, such as titanium-filled acrylic and glass-filledpolycarbonate. Diffusers 82 may also include a polycarbonate film havinga rough and prism-like surface or a titanium dioxide adhesive appliedover a distal face of distal cap 80 to cover illumination units 8 andbond illumination units 8 to distal cap 80. In some embodiments, distalcap 80 may be injection molded from any suitable, optically clearmaterial that may be loaded with 1 to 15% titanium dioxide, and thus,the material of distal cap 80 may function as a diffuser.

FIG. 15 illustrates another embodiment of a distal cap 90 according toan exemplary embodiment. Distal cap 90 may be substantially similar todistal cap 70 of FIG. 13 and distal cap 80 of FIG. 14. In addition,distal cap 90 may be configured to accommodate illumination system 21having a bundled arrangement of illumination units 8. The bundledarrangement may provide stronger illumination of a desired site forimage capture. In addition, an opening 91 for illumination units 8 mayinclude a diffuser 92, and the bundled arrangement of illumination units8 and opening 91 may also be curved around image sensor 7.

FIG. 16 illustrates a safety clip 100 coupled to ureteroscope 1according to an exemplary embodiment. Safety clip 100 may be configuredto secure ureteroscope 1 to a structure 101, such as a bed rail, drape,cabinet, and the like, such that ureteroscope 1 may be prevented fromfalling on the floor and becoming contaminated in the event ureteroscope1 slips from the user's hand. Safety clip 100 may include a firstcoupling member 102, a connecting member 103, and a second couplingmember 104. First coupling member 102 and second coupling member 104 mayinclude any suitable attachment means, such as a movable ring lock, ahook, and a lockable cuff. First coupling member 102 may be configuredto attach to ureteroscope 1 at, for example, connector 17, elongatemember 3, or a ring on handle assembly 2. Second coupling member 104 maybe configured to attach to any suitable structure 101, such as a bedrail. Connecting member 103 may connect together first coupling member102 and second coupling member 104. Connecting member 103 may becomprised of any suitable material configured to support the weight ofureteroscope 1, such as, for example, elastics, plastics, and polymericmaterials.

FIGS. 17A and 17B illustrate an interchangeable lever system 600according to an exemplary embodiment. Interchangeable lever system 600may be used with, for example, first actuator 14 and second actuator 15of steering mechanism 11, and may be configured to readily interchangemultiple different lever pads 601, 602 based on the preference of theuser. For example, lever pad 601 may be softer and smoother relative tolever pad 602, and lever pad 602 may be more rigid, rough, and mayergonomically conform to the user's thumb. The user may switch betweenlever pads 601, 602 depending on, for example, comfort and performance.

FIG. 17A shows an actuator 603, such as first actuator 14 or secondactuator 15 discussed above, with lever pads 601, 602 removed fromactuator 603. Lever pads 601, 602 may be configured to attach to anddetach from actuator 603. Actuator 603 may include a pad connectionmember 604 configured to receive either of lever pads 601, 602. Moreparticularly, connection member 604 may include a slot 605 configured toconnect to lever pads 601, 602 via a mechanical attachment, such as asnap fit.

FIG. 17B illustrates a perspective view of interchangeable lever system600 according to an exemplary embodiment. As shown in FIG. 17B, leverpad 602 (shown with portions broken away) may be attached to actuator603 via a snap fit between slot 605 of connection member 604 and a pin606 of lever pad 602. More particularly, connection member 604 may beslid into a groove 607 of lever pad 602 until slot 605 slides and lockswith pin 606. Lever pad 602 may be detached from actuator 603 by pullinglever pad 602 away from actuator 603 and releasing the snap fit. Otherlever pads, such as lever pad 601, may then be coupled to actuator 603by substantially the same configuration.

Any aspect set forth in any embodiment may be used with any otherembodiment set forth herein. Every device and apparatus set forth hereinmay be used in any suitable medical procedure, may be advanced throughany suitable body lumen and body cavity, and may be used for treatmentof any suitable body portion. For example, the apparatuses and methodsdescribed herein may be used in any natural body lumen or tract,including those accessed orally, vaginally, or rectally.

The many features and advantages of the present disclosure are apparentfrom the detailed specification, and thus, it is intended by theappended claims to cover all such features and advantages of the presentdisclosure which fall within the true spirit and scope of the presentdisclosure. Further, since numerous modifications and variations willreadily occur to those skilled in the art, it is not desired to limitthe present disclosure to the exact construction and operationillustrated and described, and accordingly, all suitable modificationsand equivalents may be resorted to, falling within the scope of thepresent disclosure.

1. A medical device, comprising: an elongate member; a handle assembly connected to the elongate member, the handle assembly housing: a steering mechanism movable relative to the handle assembly and configured to steer the elongate member; a camera system configured to capture images from a distal end of the elongate member; and an illumination system configured to provide illuminating light from the distal end of the elongate member; and a connector configured to operably connect the medical device to a control module including one or more processing units for operating the camera system and the illumination system, wherein the connector is configured to directly connect to and disconnect from the handle assembly.
 2. The medical device of claim 1, wherein the steering mechanism is configured to steer the elongate member along a first plane and a second plane different from the first plane.
 3. The medical device of claim 1, wherein the connector extends into the handle assembly and is configured to connect and disconnect the camera system and the illumination system to the control module.
 4. The medical device of claim 1, wherein the camera system includes a camera card housed within the housing assembly and configured to communicate imaging data associated with the camera system.
 5. The medical device of claim 4, wherein the camera system includes one or more wires housed within the housing assembly, wherein the one or more wires extend through the elongate member and operably connect to an image sensor at a tip of the elongate member.
 6. The medical device of claim 5, wherein the camera card and the one or more wires are configured to operably connect to the connector.
 7. The medical device of claim 1, wherein the illumination system includes one or more illumination units within the housing assembly and extending through the elongate member, wherein the one or more illumination units are configured to operably connect to the connector.
 8. The medical device of claim 1, further comprising a tool port configured to deliver a tool through the elongate member, and a fluid port configured to deliver fluid through the elongate member, wherein the tool port and the fluid port form a Y-shaped structure extending from the handle assembly.
 9. The medical device of claim 1, wherein the connector extends from the handle assembly via a connector hub, wherein the connector hub is positioned on a distal end of the handle assembly and is angled towards the elongate member.
 10. The medical device of claim 2, wherein the steering mechanism includes a first cam, a second cam, and a plurality of control members housed within the housing assembly, wherein the plurality of control members are operably coupled to the first and second cams and extend through the elongate member, and wherein the plurality of control members are coupled to a distal portion of the elongate member.
 11. The medical device of claim 10, wherein the steering mechanism includes a first actuator operably coupled to the first cam and a second actuator operably coupled to the second cam, wherein actuation of the first actuator steers the distal portion of the elongate member along the first plane, and actuation of the second actuator steers the distal portion of the elongate member along the second plane.
 12. An elongate member for a medical device, the elongate member comprising: a proximal portion including a proximal combination of layers of material configured to provide pushability of the elongate member; a medial portion including a medial combination of layers of material configured to provide passive deflection of the elongate member; and a distal portion including a distal combination of layers of material configured to provide active deflection of the elongate member, wherein the proximal combination, the medial combination, and the distal combination are different from each other.
 13. The elongate member of claim 12, wherein the elongate member houses one or more control members, one or more illumination units, an image sensor, and a working channel.
 14. The elongate member of claim 12, wherein the proximal combination includes an inner layer of a coiled material and an outer layer of a polymeric material, the medial combination includes an inner layer of a coiled material having a cut pattern and an outer layer of the polymeric material, and the distal combination includes an inner layer of a plurality of articulation joints and an outer layer of the polymeric material.
 15. The elongate member of claim 12, wherein the proximal combination includes an innermost layer of a coiled material, a middle layer of a braided material, and an outer layer of a first polymeric material; the medial combination includes an innermost layer of the coiled material, a middle layer of the braided material, and an outer layer of a second polymeric material less rigid than the first polymeric material; and the distal combination includes an innermost layer of a plurality of articulation joints, a middle layer of the braided material, and an outer layer of the second polymeric material.
 16. The elongate member of claim 12, wherein the proximal combination includes an inner layer formed of a tube having a first cut pattern and an outer layer of a polymeric material, the medial combination includes an inner layer formed of a tube having a second cut pattern different than the first laser cut pattern and an outer layer of the polymeric material, and the distal combination includes an inner layer formed of a tube having a third cut pattern different than the first cut pattern and the second cut pattern and an outer layer of the polymeric material.
 17. The elongate member of claim 13, wherein the distal combination includes a first layer of a polymeric material molded over the one or more control members, a second layer surrounding the first layer and formed of a coiled material, a third layer surrounding the first and second layers and formed of a first polymeric material, and a fourth layer surrounding the first, second, and third layers and formed of a second polymeric material different than the first polymeric material.
 18. The elongate member of claim 13, wherein the elongate member includes a tip having an opening for one or more illumination units, an opening for an image sensor, and an opening for a working channel.
 19. The elongate member of claim 18, wherein the opening for the one or more illumination units includes a diffuser.
 20. The elongate member of claim 18, wherein the opening for the one or more illumination units curves at least partially around the opening for the image sensor. 